Injection containing tirofiban hydrochloride

A tirofiban and injection technology, applied in the field of tirofiban hydrochloride injection, can solve the problems of large infusion volume and weight, increased transportation costs, and inconvenient transportation, and achieve reduced infusion volume, convenient portability, and stability good sex effect

Active Publication Date: 2010-06-02
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although using this method solves the problem that tirofiban hydrochloride can dissolve an effective amount of the main drug in about 200ml of water, the large i

Method used

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  • Injection containing tirofiban hydrochloride
  • Injection containing tirofiban hydrochloride
  • Injection containing tirofiban hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] prescription:

[0061] Tirofiban Hydrochloride 1.405g

[0062] 1,2-propanediol 100ml

[0063] Ethanol 50ml

[0064] Add water for injection to 1000ml

[0065] Adjust the pH value to 4.5 with 0.1mol / L hydrochloric acid

[0066] Preparation Process:

[0067] (1) Add the prescribed amount of 1,2-propanediol and ethanol to water for injection (30% of the total amount) at 50-60°C, stir and mix;

[0068] (2) Add 0.1-0.3% (w / v) activated carbon, heat and stir for 20 minutes, and filter to remove carbon;

[0069] (3) Add the prescribed amount of tirofiban hydrochloride into the above-mentioned solution, stir evenly, quantify to the full amount with water for injection, adjust the pH value to 4.5 with hydrochloric acid, and then filter with a 0.22 μm microporous membrane;

[0070] (4) Potting and sealing in glass ampoules (filling 10ml liquid in glass ampoules with 10ml volume), fusing and sealing;

[0071] (5) Sterilize at 116°C for 40 minutes, inspect with light, and pa...

Embodiment 2

[0073] prescription:

[0074] Tirofiban Hydrochloride 1.405g

[0075] 1,2-propanediol 50ml

[0076] Ethanol 100ml

[0077] Add water for injection to 1000ml

[0078] Adjust the pH value to 4.5 with 0.1mol / L hydrochloric acid

[0079] The preparation process is the same as in Example 1, and the glass ampoule (5ml liquid is filled in a glass ampoule with a volume of 5ml) is used for sub-packaging.

Embodiment 3

[0081] prescription:

[0082] Tirofiban Hydrochloride 2.809g

[0083] 1,2-propanediol 75ml

[0084] Ethanol 75ml

[0085] Add water for injection to 1000ml

[0086] Adjust the pH value to 6.0 with 0.1mol / L hydrochloric acid

[0087] Preparation process: the preparation process is the same as in Example 1.

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PUM

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Abstract

The invention relates to injection containing tirofiban hydrochloride and belongs to the field of pharmaceutical preparations. The injection consists of 0.05 to 0.5 percent (w/v) of tirofiban hydrochloride, 5 to 25 percent (v/v) of 1,2-propylene glycol, 5 to 25 percent(v/v) of ethanol and water, and the pH value of the injection is 3.5 to 6.5. When the injection containing the tirofiban hydrochloride is clinically used, the transfusion volume of a patient is lowered, and the injection can also be added in sodium chloride or glucose transfusion for intravenous drip of the patient, so that the patients suitable to be treated by the injection is increased, and the injection is suitable for more patients suffering from acute coronary syndromes.

Description

technical field [0001] The invention relates to a tirofiban hydrochloride injection, which belongs to the field of pharmaceutical preparations. Background technique [0002] Tirofiban is a non-peptide platelet membrane glycoprotein IIb / IIIa (GP IIb / IIIa) receptor antagonist, which has the effect of blocking platelet cross-linking and platelet aggregation. Its chemical name is (S)-N-(n-butylsulfonyl-O[4-(4-piperidinyl)butyl]-L-tyrosine, and its hydrochloride-hydrate is generally used in medicine. [0003] Tirofiban hydrochloride inhibits the binding of fibrinogen to platelet membrane G PIIb / IIIa receptors, thereby blocking platelet cross-linking and platelet aggregation. It is clinically used to treat patients with acute coronary syndrome (ACS), and it is also suitable for patients with acute coronary syndrome to undergo coronary angioplasty or intracoronary plaque resection, which can reduce death, myocardial infarction, and refractory Incidence of the composite endpoint o...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4465A61K47/10A61P9/10
Inventor 赵志全
Owner LUNAN PHARMA GROUP CORPORATION
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